Medical Devices in Academic Research Symposium

Wednesday

,

October

16

,

2019

RSVPs Closed

Join other investigators, regulatory experts, and study teams to learn about the new developments in the medical device regulatory landscape and discuss the benefits and challenges that this technology has brought to investigator initiated research.

WHY ATTEND?

Medical devices drive clinical care, whether in the form of a surgeon’s scalpel, a simple blood test, or a complex imaging machine. With the technological innovation and advances made in precision medicine, 3-D printing, and mobile medical applications, these devices are now a large part of the research landscape here at Michigan Medicine.

As the rapid advances in technology outpace changes in regulation, FDA oversight and the regulatory requirements have become more challenging for academic investigators and regulatory support staff. These sessions will provide relevant, timely information to advance your research.

WHO IS THIS FOR?

This is a first-of-its kind session tailored to academic research, academic investigators, and regulatory support staff.

Feel free to attend any or all sessions

RSVPs Closed

Free of charge*

If you are unable to attend this workshop, please cancel your registration to release a seat for someone else who may be waiting to sign up. If you do not cancel by two weeks prior to the workshop, your department will be billed a $50.00 cancellation fee.

Symposium Overview

Join other investigators, regulatory experts, and study teams at the
Medical Device in Academic Research Symposium to learn about the new developments in the medical device regulatory landscape and
discuss the benefits and challenges that this technology has brought
to investigator initiated research.
Topics will include:
• Next Gen Sequencing for Precision Medicine Trials
• 3-D Printed Devices
• Design Controls
• Medicare Reimbursement
• Digital Health and the use of Artificial

Symposium Overview

Join other investigators, regulatory experts, and study teams at the
Medical Device in Academic Research Symposium to learn about the
new developments in the medical device regulatory landscape and
discuss the benefits and challenges that this technology has brought
to investigator initiated research.
Topics will include:
• Next Gen Sequencing for Precision Medicine Trials
• 3-D Printed Devices
• Design Controls
• Medicare Reimbursement

The Schedule

8:00 - 8:30 AM

Registration and Continental Breakfast

8:30 - 8:45 AM

Welcome and Introductions

Kevin Weatherwax, Managing Director, Michigan Institute for Clinical and Health Research (MICHR)

8:45 - 9:45 AM

Keynote: New Challenges of In Vitro Diagnostics

Brian J. Malkin, JD, Arent Fox LLP

9:45 - 10:00 AM

Break

10:00 - 10:45 AM

Panel Discussion: Regulatory Challenges of Precision Medicine

Moderator: Brian J. Malkin, JD, Arent Fox LLP

- Minimal Residual Disease IVD

Daniel Boyer, MD, Assistant Professor, Pathology
- Genetic and Biomaker Testing

Robertson Davenport, MD, Professor, Pathology, and Vice-Chair, IRB C2 Board

- Mouse Avatars of Specific Patients

Goutham Narla, MD, PhD, Division Chief, Genetic Medicine

10:45 - 11:45 AM

Regulation of Artificial Intelligence and Machine Learning in Research

Bradley Merrill Thompson, JD, Epstein Becker Green Law

11:45 - 12:45 PM

Lunch

12:45 - 1:45 PM

Design Controls: What are they and Do I need them?

Gene Parunak, Managing Director, In2Being

1:45 - 2:30 PM

CLIA and Laboratory Developed Tests: Research versus Clinical Use

James A. Boiani, JD, Epstein Becker Green Law

2:30 - 2:45 PM

Break

2:45 - 3:30 PM

IDE Device Study Reimbursement Process

Ron Podraza, JD, Chief Executive Officer and Co-Founder, Reimbursement Principles, Inc.

3:30 - 4:15 PM

Expanded Access as an Early Feasibility Study: 3D Printed Bioresorbable Airway Splint

Andrea Les, PhD, Senior Project Manager, U-M Cardiac Surgery

4:15 - 4:30 PM

Closing Remarks

Jeanne Wright, RN, BSN, RAC, Administrative Program Director, University of Michigan IND/IDE Assistance Program (MIAP)

LOCATION

Feel free to attend any or all sessions

RSVPs Closed

THIS EVENT IS BROUGHT TO YOU BY

The SCHEDULE

8:00 - 8:45 AM

Registration and Continental Breakfast

8:45 - 9:00 AM

Welcome and Introductions

George Mashour, MD, PhD, Director, Michigan Institute for Clinical and Health Research (MICHR)

9:00 - 10:00

Keynote: New Challenges of In Vitro Diagnostics

TBD

10:00 - 10:15 AM

Break

10:15 - 11:00 AM

Panel Discussion: Regulatory Challenges of Precision Medicine

Moderator: CTSA Regulatory Staff

- Minimal Residual Disease IVD

Daniel Boyer, MD, Assistant Professor, Pathology
- Genetic Sequencing of Cancer Tumors (MiOncoSeq)

Arul Chinnaiyan, MD, PhD, Director, Michigan Center for Translational Pathology

- Mouse Avatars of Specific Patients

Goutham Narla, MD, PhD, Division Chief, Genetic Medicine

6:45 - 7:30 PM

Sip, Snack and Chat

Drop your business card in the bowl on your way out for a chance to win free lunch for your team.

Topics

New Challenges of In Vitro Diagnostics

Minimal Residual Disease IVD

Genetic Sequencing of Cancer Tumors (MiOncoSeq)

Mouse Avatars of Specific Patients

Design Controls: What are they?

Regulation of Artificial Intelligence and Machine Learning in Research

CLIA and Laboratory Developed Tests: Research versus Clinical Use

IDE Device Study Reimbursement Process

Expanded Access as an Early Feasibility Study: 3D Printed Bioresorbable Airway Splint

Free of charge*

If you are unable to attend this workshop, please cancel your registration to release a seat for someone else who may be waiting to sign up. If you do not cancel by two weeks prior to the workshop, your department will be billed a $50.00 cancellation fee.

The price of light is less than the cost of darkness.

— jane e. doe

the venue

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